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- Mayne Pharma (MYX) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for its new contraceptive pill
- The new drug is an oral contraceptive for the prevention of pregnancy and if approved, it is expected to be on the market by early next year
- The company and its manufacturing partner, Mithra, have created a copy of estetrol through a complex plant-based process
- Estetrol is a naturally occurring estrogen that is produced during pregnancy
- Mayne Pharma CEO Scott Richards says this NDA filling is a major milestone for the company and Mithra
- Company shares are up 8.70 per cent on the market and are trading for 37.5¢ apiece
Mayne Pharma (MYX) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for its new contraceptive pill.
Its drug, E4/DRSP, is an oral contraceptive for the prevention of pregnancy. If approved, the contraceptive is expected to be on the market by early next year.
The pill contains Estetrol (E4), which is a naturally occurring estrogen that is produced by the human fetal liver during pregnancy.
For more than 20 years, Mayne and its manufacturing partner, Mithra, have copied E4 through a complex plant-based production process.
Estetrol will be the first estrogen introduced to the U.S. in approximately 50 years.
Mayne’s CEO Scott Richards says this NDA filling is a major milestone for the company and Mithra.
“We are now one step closer to making this new oral contraceptive that we believe to be safe, effective and well-tolerated available to American women,” he said.
In the United States, the combined hormonal contraceptives is more than US$4 billion per annum, with 10 million American women using oral pills, patches or vaginal rings each day.
“E4/DRSP is now filed in the U.S. and Europe and we are actively working with our
partners for the commercial launch of this product around the world,” Mithra’s CEO Francois Fornieri said.
“E4/DRSP promises to provide women with a new choice in oral contraception, in a space where there haven’t been any new innovative hormones introduced for many decades,” he added.
The company completed two phase 3 clinical studies and Mitchell Creinin, Professor and Director of Family Planning at the University of California, is excited to see the overall results.
“I am excited to see the overall results for E4/DRSP from two phase 3 clinical studies including more than 4400 women around the world that demonstrated very positive outcomes for efficacy and safety in a product that achieved a
desirable bleeding profile and excellent tolerability,” he stated.
Company shares are up 8.70 per cent on the market and are trading for 37.5¢ apiece at 11:42 am AEST.
